NCT03067688

Brief Summary

Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 11, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2018

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

February 1, 2017

Last Update Submit

January 14, 2019

Conditions

HypertensionHyperlipidemia

Outcome Measures

Primary Outcomes (2)

  • Mean sitting systolic blood pressure (MSSBP)

    MSSBP change form the baseline at Week 8

    Baseline, Week 8

  • Low density lipoprotein cholesterol (LDL-C)

    LDL-C change form the baseline at Week 8

    Baseline, Week 8

Secondary Outcomes (8)

  • MSSBP (Mean sitting systolic blood pressure)

    Baseline, Week 4

  • Mean sitting diastolic blood pressure (MSDBP)

    Baseline, Week 4, Week 8

  • Low density lipoprotein cholesterol (LDL-C)

    Baseline, Week 4

  • Total Cholesterol (TC)

    Baseline, Week 4, Week 8

  • High density lipoprotein cholesterol (HDL-C)

    Baseline, Week 4, Week 8

  • +3 more secondary outcomes

Study Arms (3)

"Combination drug:Temisartan+Amlodipine+Rosuvastatin"

EXPERIMENTAL

60 subjects will be assigned and the subjects will be administered "Temisartan+Amlodipine+Rosuvastatin" for 8 weeks.

Drug: Temisartan+Amlodipine+Rosuvastatin (Combination drug)

Temisartan+Amlodipine

ACTIVE COMPARATOR

60 subjects will be assigned and the subjects will be administered "Twynsta Tab.(Temisartan+Amlodipine)" for 8 weeks.

Drug: Temisartan+Amlodipine

Temisartan+Rosuvastatin

ACTIVE COMPARATOR

60 subjects will be assigned and the subjects will be administered "Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin)" for 8 weeks.

Drug: Temisartan+Rosuvastatin

Interventions

Temisartan+Amlodipine+Rosuvastatin (Combination drug)DRUG

PO, Once daily(QD), 8weeks

Also known as: Twynsta Tab.+Crestor Tab.
"Combination drug:Temisartan+Amlodipine+Rosuvastatin"
Temisartan+AmlodipineDRUG

PO, Once daily(QD), 8weeks

Also known as: Twynsta Tab.
Temisartan+Amlodipine
Temisartan+RosuvastatinDRUG

PO, Once daily(QD), 8weeks

Also known as: Micardis Tab.+Crestor Tab.
Temisartan+Rosuvastatin

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Subjects with hypertension and hyperlipidemia

You may not qualify if:

  • Patients with known or suspected secondary hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Natuional University Hospital

Seoul, Jongno, 03080, South Korea

Location

Related Publications (1)

  • Jin X, Kim MH, Han KH, Hong SJ, Ahn JC, Sung JH, Cho JM, Lee HC, Choi SY, Lee K, Kim WS, Rhee MY, Kim JH, Hong SP, Yoo BS, Cho EJ, Lee JH, Kim PJ, Park CG, Hyon MS, Shin JH, Lee SH, Sung KC, Hwang J, Kwon K, Chae IH, Seo JS, Kim H, Lee H, Cho Y, Kim HS. Efficacy and safety of co-administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia. J Clin Hypertens (Greenwich). 2020 Oct;22(10):1835-1845. doi: 10.1111/jch.13893. Epub 2020 Sep 16.

    PMID: 32937023DERIVED

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

Drug Combinationstelmisartan amlodipine combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

  • Hyunhee Na, MD

    Yuhan Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2017

First Posted

March 1, 2017

Study Start

April 11, 2017

Primary Completion

March 27, 2018

Study Completion

March 27, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)